LEAD
This device is manufactured by LIVANOVA USA.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Shock from Patient Lead(s) | 1 | Patient |
| 2024 | Fibrosis | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Convulsion, Clonic | 2 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Naturally Worn | 4 | Device |
| 2024 | Migration | 1 | Device |
| 2024 | Low impedance | 2 | Device |
| 2024 | High impedance | 7 | Device |
| 2024 | Fracture | 23 | Device |
| 2024 | Electrical Shorting | 2 | Device |
| 2024 | Device Contamination with Body Fluid | 2 | Device |
| 2024 | Corroded | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Scar Tissue | 1 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Convulsion, Clonic | 3 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Naturally Worn | 2 | Device |
| 2023 | Low impedance | 3 | Device |
| 2023 | High impedance | 9 | Device |
| 2023 | Fracture | 38 | Device |
| 2023 | Electrical Shorting | 2 | Device |
| 2023 | Device Contamination with Body Fluid | 3 | Device |
| 2023 | Corroded | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Shock from Patient Lead(s) | 1 | Patient |
| 2022 | Implant Pain | 2 | Patient |
| 2022 | Discomfort | 1 | Patient |
| 2022 | Convulsion, Clonic | 1 | Patient |
| 2022 | Output below Specifications | 1 | Device |
| 2022 | Naturally Worn | 3 | Device |
| 2022 | Low impedance | 1 | Device |
| 2022 | High impedance | 4 | Device |
| 2022 | Fracture | 22 | Device |
| 2022 | Device Contamination with Body Fluid | 4 | Device |
| 2022 | Corroded | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2021 | Shock from Patient Lead(s) | 1 | Patient |
| 2021 | Headache | 1 | Patient |
| 2021 | Discomfort | 1 | Patient |
| 2021 | Convulsion, Clonic | 1 | Patient |
| 2021 | Low impedance | 1 | Device |
| 2021 | High impedance | 1 | Device |
| 2021 | Fracture | 10 | Device |
| 2021 | Electrical Shorting | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2020 | Fracture | 6 | Device |